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Набор по приглашению NCT07486284

Ultrasound Elastography of Carpal Tunnel Syndrome

— Наблюдательное Carpal Tunnel Syndrome (CTS)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Ultrasound Elastography.
Кому может быть актуально
Состояния в реестре: Carpal Tunnel Syndrome (CTS). Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Вьетнам
Следующий шаг
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Официальное название

Study on the Characteristics of Ultrasound Elastography in the Evaluation of Carpal Tunnel Syndrome

Обзор

Carpal Tunnel Syndrome (CTS) is the most common peripheral nerve compression disorder in adults. Although electromyography (EMG) is the current gold standard for diagnosis, it is invasive, time-consuming, and may yield false-negative results. Ultrasound elastography, including shear wave elastography and strain elastography, enables non-invasive assessment of median nerve stiffness, reflecting fibrosis and edema. However, data on the combined use of elastography and microvascular imaging in CTS are still limited in Vietnam. This study aims to evaluate the value of advanced ultrasound techniques in diagnosing CTS and grading disease severity, as well as their correlation with clinical symptoms and EMG findings

Вмешательства

  • Процедура Ultrasound Elastography
    * Shear Wave Elastography (SWE): * Performed in the longitudinal plane at the carpal tunnel inlet. * A Region of Interest (ROI) of 1mm will be placed on the median nerve (excluding epineurium). * Stiffness will be measured in kilopascals (kPa). * Three measurements will be taken and averaged. * Strain Elastography (SE): * Assessed using a color map overlay (Blue/Green/Red). * Grading scale (1-4): Grade 1 (Soft/Red) to Grade 4 (Hardest/Blue).

Первичные конечные точки

  • Diagnostic Accuracy of Shear Wave Elastography for Carpal Tunnel Syndrome [Срок оценки: At baseline (data collected at the time of retinal examination during the study period from April 2025 to February 2026)]
  • Diagnostic Accuracy of Strain Elastography (SE) for Carpal Tunnel Syndrome [Срок оценки: At baseline (data collected at the time of retinal examination during the study period from April 2025 to February 2026)]
  • Diagnostic Accuracy of Median Nerve Cross-Sectional Area (CSA) for Carpal Tunnel Syndrome [Срок оценки: At baseline (data collected at the time of retinal examination during the study period from April 2025 to February 2026)]
Вторичные конечные точки (2)
  • Correlation [Срок оценки: At baseline (data collected at the time of retinal examination during the study period from April 2025 to February 2026)]
  • Cut-off Values [Срок оценки: At baseline (data collected at the time of retinal examination during the study period from April 2025 to February 2026)]

Критерии участия

Критерии включения

Inclusion Criteria (Case Group)

  • Patients >18 years old.
  • Clinical suspicion of CTS with at least one sign: numbness/pain in the median nerve distribution (digits 1, 2, 3, and lateral 4), nocturnal symptoms, or positive provocative tests (Tinel, Phalen, Durkan).
  • Confirmed diagnosis of CTS via Electrodiagnostic studies (NCS/EMG) based on American Academy of Neurology (AAN) and AANEM criteria.

Inclusion Criteria (Control Group)

  • Healthy volunteers with no clinical symptoms of CTS.
  • Normal electrodiagnostic results.

Критерии исключения

  • Exclusion Criteria
  • History of prior CTS treatment (steroid injection, surgery).
  • Presence of cervical radiculopathy, polyneuropathy, or proximal median nerve entrapment.
  • Secondary causes of CTS identified on ultrasound (e.g., gouty tophi, ganglion cysts, tumors, tenosynovitis).
  • Anatomical variants such as a bifid median nerve or persistent median artery.
  • Refusal to participate in the study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Вьетнам · 1 центр
  • Da Nang family general Hospital — Da Nang

Публикации

  • 1. El-Shewi, Islam El-Hefnawi et al. (2024), "Role of conventional ultrasound and shear wave elastography of median nerve in diagnosis and differentiation of carpal tunnel syndrome severity in correlation with electrodiagnostic studies", Egyptian Journal of Radiology and Nuclear Medicine. 55(1), tr. 53. 2. Joshi, Aditya et al. (2022), "Carpal tunnel syndrome: pathophysiology and comprehensive guid

Идентификаторы

NCT: NCT07486284 · 01/2025/BVGĐ-HĐĐĐ · 01/2025/BVGĐ-HĐĐĐ

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗